Processors of food packaging are in for some bureaucratic surprises

Thanks to a recent European Union directive (2002/72/EC), processors and food packagers are now required to analyze whether the product they put onto the market complies with stricter limits on migration of substances from plastics to food.

The measure applies not only to the 25 members of the EU, but all food products packaged in plastics that are imported from abroad. The basic EU law on food contact materials requires that these not endanger human health, which is interpreted as an obligation to use substances that do not migrate to foodstuffs in quantities that could cause illness, and that are manufactured under good manufacturing practices, says Luigi Rossi, the EU Commission''s expert advising the plastics community on the new measures.

Use of many substances is restricted by a so-called Specific Migration Limit (SML) expressed in milligrams of a substance allowed to migrate from any plastics into 1 kg of food under specific conditions.

Confirmation of compliance generally involves lab tests, but the Commission has agreed to recognize mathematical modeling to estimate maximum possible specific migration.

To the rescue comes online plastics and additives service SpecialChem (Paris), together with two other partners: PIRA International, a business consultancy, and FABES GmbH, a research firm). They will offer online migration modeling software that should help estimate migration and determine if packaging design complies with EU directives.

Easing compliance

"Our study showed that a lack of awareness in the industry regarding the new implication of the directive is common," says SpecialChem founder Christophe Cabarry. Traditional lab testing of packaging can be costly and time consuming. He believes the migration modeling system in MigraPass should considerably speed up compliance assurance.

MigraPass'' algorithms, based on actual lab migration studies, were developed by FABES (Munich, Germany). The online service has been approved as "an appropriate testing method" by the EU commission. So far it is the only such program on the market for this application. Once logged on to the MigraPass site (www.migrapass.com), processors key in thickness, resin type, packaging structure, additives and fillers used, and foodstuff packaged, along with other characteristics. The results are calculated and a Migration Report and Specific Migration Limit compliance certificate are returned indicating whether EU standards are met.

One drawback is that the modeling system applies to monolayer structures only. Cabarry says multilayers still require lab testing.

Multilayers are expected to be included in a "Super-Regulation," which is now under consideration, says Ralph A. Simmons, partner in the Washington, DC law firm Keller and Heckman, which is closely following developments in Europe. The draft of the Super-Regulation would provide other means of obtaining compliance based on scientific evidence in order to avoid unnecessary testing (see related story, next page).

These would include testing materials of similar composition generally recognized as worst-case for migration, when the sum of migration of various layers is less than the total migration limitations, or if it can be shown that the manufacturing process is reproducible.

Robert Colvin [email protected]

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